What is the mechanism of action of this treatment?

Aerobic exercise is believed to improve cognitive function in dementia patients by enhancing vascular function and cerebrovascular reserve. This is achieved through increased cerebral blood flow and better regulation of blood vessels in the brain, which can mitigate age-related declines in brain health. These improvements are crucial for dementia patients as they help maintain cognitive performance and potentially slow the progression of cognitive decline. Additionally, aerobic exercise may influence molecular and cellular changes, such as reducing inflammation and promoting neurogenesis, further supporting brain health.

What side effects are associated with this type of intervention?

Common treatments for dementia include pharmacologic therapies such as cholinesterase inhibitors (e.g., donepezil, galantamine) and memantine, as well as nonpharmacologic therapies like aerobic exercise. Cholinesterase inhibitors can cause side effects such as gastrointestinal issues (nausea, diarrhea), insomnia, muscle cramps, and fatigue. Memantine may lead to dizziness, headache, confusion, and constipation. Aerobic exercise, which is being studied for its potential to improve vascular function and cerebrovascular reserve, generally has fewer side effects, primarily related to physical strain or injury if not performed correctly. Overall, exercise is considered safe and beneficial for cognitive function and physical health.

What prior FDA approvals exist?

FDA-approved drugs for the treatment of dementia include acetylcholinesterase inhibitors such as donepezil and galantamine, and the NMDA receptor antagonist memantine. These medications primarily work by enhancing neurotransmitter activity to improve cognitive function. While these drugs do not specifically target vascular function or cerebrovascular reserve, aerobic exercise has shown promise in these areas by improving vascular health and blood flow to the brain, which may offer complementary benefits to traditional pharmacological treatments.

What other types of research exist?

Promising alternatives to aerobic exercise for dementia patients include: 1) Resistance training, which has been shown to improve vascular function and physical capacity in related conditions like peripheral artery disease. 2) Mindfulness-based interventions, such as yoga and Tai Chi, which can enhance cognitive function and reduce fall risk. 3) Dietary approaches like the MIND and Mediterranean diets, which are associated with delayed onset and reduced progression of neurodegenerative diseases. 4) Multidisciplinary rehabilitation programs that combine physical, cognitive, and emotional therapies to improve overall brain health.

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Aerobic Exercise for Alzheimer's Disease (BIMII Trial)

N/A

Recruiting

Led By Marc J Poulin, PhD, DPhil

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Not fluent in verbal and written English

History of stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be assessed at 6, 12 and 18 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether regular aerobic exercise can help prevent dementia in older adults with memory issues. The exercise program aims to improve brain health by boosting blood flow and fitness. Researchers hope to show that this can slow down or prevent cognitive decline.

Who is the study for?

This trial is for inactive adults aged 50-80 with memory complaints but no dementia, and at least one vascular risk factor like high blood pressure or diabetes. They should not be doing vigorous exercise more than twice a week and must speak English fluently. People with serious illnesses, history of stroke, or other conditions that could affect the study can't join.

What is being tested?

The trial tests if regular aerobic exercise can prevent or slow down cognitive decline in older adults at risk of Alzheimer's Disease and related dementias (ADRD). Participants will do either aerobic exercises or stretching-toning exercises to see which helps brain health and cognition more.

What are the potential side effects?

While the trial focuses on beneficial effects, potential side effects from increased physical activity may include muscle soreness, fatigue, joint pain, and an elevated risk of injury. The intensity will be monitored to minimize these risks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not fluent in English.

Select...

I have had a stroke in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be assessed at 6, 12 and 18 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be assessed at 6, 12 and 18 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed at 6, 12 and 18 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Blood Biomarkers Assessed by Elisa Assays

Change in Health behaviour with appropriate support strategies

Change in Maximal Oxygen Uptake (VO2max) Assessed by Metabolic Cart

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stretch and StrengthExperimental Treatment1 Intervention

A control group will meet on a similar schedule as the exercise group for sessions on stretching and toning but without aerobic exercise. Based on prior RCTs of similar interventions the investigators expect this control to be ineffective or minimally effective, but anticipate that it will increase participant enthusiasm and retention. All assessments will be conducted in this arm.

Group II: Aerobic exerciseExperimental Treatment1 Intervention

Participants will take part in a supervised 6-month-long aerobic (walk/jog) training program held 3 days/week. Each session will include a 5-min warm-up, 20-40 min of aerobic exercise (walking, jogging), 5-min cool-down, and stretching. Exercise prescriptions will follow current principles and guidelines established by ACSM/AHA, including sufficient warm-up, cool-down, and ongoing provision of safety precautions/exercise tips. As participants progress, the duration of aerobic exercise will increase from 20 (month 1) to 30 (months 2-3) and 40 min (months 4-6), with proportional increases to warm-up and cool-down periods. Exercise intensity will be based on individual maximal oxygen uptake (VO2 max), measured at baseline. Intensity will build from 30-45% (months 1-3) to mitigate the risk of injury and will progress to 60-70% (months 4-6) heart rate reserve (HRR).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic exercise

2000

Completed Phase 2

~1130

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aerobic exercise is believed to improve cognitive function in dementia patients by enhancing vascular function and cerebrovascular reserve. This is achieved through increased cerebral blood flow and better regulation of blood vessels in the brain, which can mitigate age-related declines in brain health. These improvements are crucial for dementia patients as they help maintain cognitive performance and potentially slow the progression of cognitive decline. Additionally, aerobic exercise may influence molecular and cellular changes, such as reducing inflammation and promoting neurogenesis, further supporting brain health.

Exercise as Potential Therapeutic Target to Modulate Alzheimer's Disease Pathology in APOE ε4 Carriers: A Systematic Review.Galantamine for vascular cognitive impairment.